Vicks Vaporub Inhalation Vapour, Ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CAMPHOR, EUCALYPTUS OIL, TURPENTINE OIL, LEVOMENTHOL

Available from:

WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH Sulzbacher Str. 40, 65823, Schwalbach am Taunus,, Germany

ATC code:

R05X

INN (International Name):

CAMPHOR 5 % (W/W) EUCALYPTUS OIL 1.5 % (W/W) TURPENTINE OIL 5 % (W/W) LEVOMENTHOL 2.75 % (W/W)

Pharmaceutical form:

INHALATION VAPOUR, OINTMENT

Composition:

CAMPHOR 5 % (W/W) EUCALYPTUS OIL 1.5 % (W/W) TURPENTINE OIL 5 % (W/W) LEVOMENTHOL 2.75 % (W/W)

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-03-02

Patient Information leaflet

PATIENT INFORMATION LEAFLET
IN THIS LEAFLET:
1.
WHAT VICKS VAPORUB IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE VICKS VAPORUB
3.
HOW TO USE VICKS VAPORUB
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE VICKS VAPORUB
6.
FURTHER INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION
FOR YOU.
This medicine is available without prescription. However, you still
need to
use Vicks VapoRub carefully to get the best results from it.
- KEEP THIS LEAFLET. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
1.
WHAT VICKS VAPORUB IS AND WHAT IT IS USED FOR
Vicks VapoRub is an ointment which is used to relieve nasal catarrh
(inflammation of mucous membranes in the nose and throat), congestion
(a blocked nose), sore throat and coughs due to colds. Vicks VapoRub
contains
four active ingredients: Camphor, Turpentine oil, Levomenthol and
Eucalyptus oil.
• Levomenthol and camphor calm a cough
• Eucalyptus oil and Levomenthol relieve nasal congestion (blocked
nose)
• Eucalyptus oil relieves catarrh
2.
BEFORE YOU USE VICKS VAPORUB
DO NOT USE VICKS VAPORUB:
• if you are allergic to any of the actives or other ingredients
(see section 6)
• on children under 2 years
• as an inhalation for children under 6 years
• on broken skin, wounds or mucous membranes
• swallow or apply directly onto the nostrils, eyes, mouth or face
Do not bandage tightly.
Do not use with heat wrap.
Do not use boiling water to prepare inhalations.
Do not heat or re-heat the mixture in a microwave.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine if you:
• have a history of airway disease or asthma
Do not smoke or go near naked flames - risk of severe burns. Fabric
(clothing, bedding,
dressings, etc) that has been in contact wit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vicks Vaporub Inhalation Vapour, Ointment
Levomenthol 2.75 % w/w
Camphor 5.00 % w/w
Eucalyptus oil 1.50 % w/w
Turpentine oil 5.00 % w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of the active substances Quantity Unit
Levomenthol 2.75 % w/w
Camphor 5.00 % w/w
Eucalyptus oil 1.50 % w/w
Turpentine oil 5.00 % w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation vapour, ointment
A soft, white or yellow unctuous ointment with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of nasal catarrh and congestion, sore
throat, also cough due to
colds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TOPICAL
Adults and children over 2 years
Rub the indicated amount onto the areas indicated (e.g. chest, back)
and repeat up to 2-4
times a day as needed. Wear loose clothing to facilitate the
inhalation of the vapours.
INHALATION
Adults and children over 6 years:
Place 1 – 2 x 5ml Spoonfuls as indicated into a bowl of hot (not
boiling) water. Inhale the
vapours for up to 10 – 15 minutes per time. Do not heat in the
microwave or reheat this
mixture. Children should always be supervised.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Do not administer to children < 2 years.
Do not use as an inhalation for children < 6 years
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The following patient groups should use with caution or consult a
doctor before use;
History of airway disease or pronounced hypersensitivity of the
airways / asthma
Keep out of reach and sight of children.
If symptoms persist, consult your doctor
TOPICAL:
Do not apply to broken skin, wounds or mucous membranes.
Do not swallow or apply directly onto the nostrils, eyes, mouth or
face.
For external use only
Do not bandage tightly. Do not use with heat wrap.
INHALATION:
Do not use boiling water to prepare inhalations.
Do not heat or re-heat the mixture in a microwave.
4.5 INTERACTION WITH OTHER MEDICIN